Actively controllable heart valve implant and method of controlling same

ABSTRACT

A mitral valve implant includes a force-expanding mitral valve lattice having an interior orifice and a self-expanding valve trampoline attached at the interior orifice of the force-expanding mitral valve lattice. The mitral valve lattice is self-expandable to a first configuration and force expandable from the first configuration to a second configuration. The configurations can be circular or D-shaped. The mitral valve lattice comprises jack screws adjusting configurations of the mitral valve lattice. The valve trampoline has a cylindrical central region comprising valve leaflets. An outwardly flaring implant skirt is attached to the mitral valve lattice exterior. Wall-retaining wires are attached to the mitral valve lattice, are petal-shaped, and have a pre-set, radially outward, memory shape. The wires and skirt impart a force on a respective side of the native mitral valve when the mitral valve lattice is expanded within an annulus of the native mitral valve.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application:

-   -   claims the priority, under 35 U.S.C. § 119, of U.S. Provisional        Patent Application No. 62/182,820, filed Jun. 22, 2015; and    -   claims the priority, under 35 U.S.C. § 119, of U.S. Provisional        Patent Application No. 62/183,451, filed Jun. 23, 2015;        the prior applications are herewith incorporated by reference        herein in their entireties.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

Not Applicable

FIELD OF THE INVENTION

The present invention lies in the field of heart valve implants(including mitral, aortic, pulmonary, and tricuspid), and methods andsystems for controlling and implanting heart valves.

BACKGROUND OF THE INVENTION

The human heart can suffer from various valvular diseases, which canresult in significant malfunctioning of the heart and ultimately requirereplacement of the native heart valve with an artificial valve. Thereare a number of known artificial valves and a number of known methods ofimplanting these artificial valves in humans.

One method of implanting an artificial heart valve in a human patient isvia open-chest surgery, during which the patient's heart is stopped andthe patient is placed on cardiopulmonary bypass (using a so-called“heart-lung machine”). In one common surgical procedure, the diseasednative valve leaflets are excised and a prosthetic valve is sutured tothe surrounding tissue at the native valve annulus. Because of thetrauma associated with the procedure and the attendant duration ofextracorporeal blood circulation, some patients do not survive thesurgical procedure or die shortly thereafter. It is well known that therisk to the patient increases with the amount of time required onextracorporeal circulation. Due to these risks, a substantial number ofpatients with defective native valves are deemed inoperable becausetheir condition is too frail to withstand the procedure.

Because of the drawbacks associated with conventional open-chestsurgery, percutaneous and minimally-invasive surgical approaches are insome cases preferred. In one such technique, a prosthetic valve isconfigured to be implanted in a much less invasive procedure by way ofcatheterization. For instance, U.S. Pat. Nos. 7,393,360, 7,510,575, and7,993,394 describe collapsible transcatheter prosthetic heart valvesthat can be percutaneously introduced in a compressed state on acatheter and expanded to a functional size at the desired position byballoon inflation or by utilization of a self-expanding frame or stent.

Various heart valve replacement devices exist in the art and, during thepast decade, advancements in valve replacement implants have beenachieved. Many of these advancements have occurred with those implantsdelivered percutaneously in a compressed state on a catheter and, withouter sheath retraction, self-expand to a given extent for implantation.Some implants are made of entirely self-expanding structures. Otherimplants partially self-expand and then are further expanded by force.Such dual-expansion implants can be made from a single, substantiallycylindrical, lattice structure having a pre-defined (e.g., heat-set)initial shape that is smaller than the intended implantation diameter ofan anatomic orifice, such as a vessel or heart valve. The lattice can bemade of nitinol, for example. A lattice of non-self-expanding materialcan also be used, for example, of a cobalt chromium material. Within thelattice there can be a set of adjustable expansion devices that placerespective forces upon the lattice to elastically and/or plasticallydeform the lattice to a size that is even greater than the pre-definedshape. One example of the expansion devices is a set of jack screws thatare controlled by rotating drive wires (which wires extend from theimplant location to the environment outside the patient and terminate,for example, at an electronic delivery control handle). As shown in U.S.Patent Application Publication Nos. 2013/0046373, 2013/0166017, and2014/0296962, these rotating wires are initially connected to arespective jack screw and rotation of each wire causes a correspondingrotation of the jack screw. With the jack screws being connected to thelattice on each of their opposing ends (for example, through a threadedconnection on one end and a freely rotating but longitudinally fixedconnection on the other), rotation in one direction expands thecircumference of the lattice and rotation in the other directioncontracts the lattice. These control wires can be connected to thedelivery handle with temporary securement structures that keep the wiresrotationally connected to the respective jack screw until implantationand release of the replacement valve is desired. Before beingdisconnected, the control wires can reversibly expand and contract thelattice as the surgeon desires for optimal placement in the installationlocation. In other words, such implants can be repositioned before finaldeployment. When the implant is positioned in a final desiredorientation, the drive wires are disconnected from all of the jackscrews and are removed from the patient.

One advantage that such implants have over entirely self-expandinglattices is that these implants can be carefully expanded and also canprovide feedback to the operator as to the device diameter and forcesencountered from surrounding tissue. In contrast, entirelyself-expanding implants continuously expand and apply an outwardlydirected force where the lattice is implanted. The final diameter of theimplant is not finely controllable or adjustable. Expansion of thetissue could lead to paravalvular leakage, movement of the implant,and/or embolism, all of which are undesirable.

Another feature of lattice implants that, upon deployment, firstself-expand when removed from the installation catheter and then areforcibly expanded into the delivery site (referred to asself-expanding/forcibly expanding) is the fact that the force impartedagainst the tissue can be measured (and/or calculated) and eitherminimized or set to a desired value. While rotating the drive wires, anytorque applied to the drive wires can be measured and determined with animplant delivery and deployment system having sensors (e.g., electronicsensors) that measure various parameters, such as current draw forexample. Rotation of the drive wires for expanding the implant can behalted when a value of the determined torque is reached.

Delivery of implants in the art for replacement or repair of a heartvalve can be achieved over different avenues. One percutaneous way thatimplant delivery can occur is through the aorta, where the entry site inthe patient is located adjacent the femoral artery, referred to as thetransfemoral (TF) approach. Another route to implantation of areplacement valve is through a transapical approach. Aortic replacementvalves installed in these manners are referred to as TranscatheterAortic Valve Replacement (TAVR) and Transcatheter Aortic ValveImplantation (TAVI) surgeries, which can be transapical. A third paththrough the septum of the heart is also possible and one such procedureis referred as a Transseptal (TS) Antegrade Transcatheter Aortic ValveReplacement.

For the treatment of mitral valve disease, Transcatheter Mitral ValveReplacement (TMVR) has been the subject of study, but has not beenwidely commercialized. Current TMVR techniques have several limitations.First, the size of the valves that are available for TMVR implant maynot fit well. In particular, the mitral valve is not substantiallycircular, it has a D-shape with a long curving interface between themitral valve's native leaflets. This is in contrast to the aortic valve,which is substantially circular. Also, the TMVR devices do not tend toallow for repositioning of the implant once it has been deployed inplace. Next, the final expanded diameter of the known TMVR devices ispre-determined, making pre-sizing by a doctor a critical and difficultstep. The physician must remotely assess the size of the diseased valvefor selecting the correct implant. Migration of existing mitral valveimplants is a significant clinical problem, potentially causing leakageand/or compromising necessary vascular supply. In such situations,emergency open surgery can be required, and/or it can lead to anunstable seal and/or migration.

No commercially approved transcatheter mitral valve exists. Some arebeing studied but there is no replacement mitral valve that can be fullyrepositioned during deployment and adjusted to better accommodate andseal a natural, diseased mitral valve. Thus, a need exists to overcomethe problems with the prior art systems, designs, and processes asdiscussed above.

SUMMARY OF THE INVENTION

Embodiments of the systems, apparatuses, and methods described hereinrelate to an actively controllable implant or heart valve implant andmethods of controlling same that overcome the hereinafore-mentioneddisadvantages of the heretofore-known devices and methods of thisgeneral type and that provide such features with the ability to be fullyrepositioned before final deployment.

Described herein are various systems, apparatuses, and methods forimplanting replacement heart valves, which implants can be used in anyvalve of the heart. In some exemplary embodiments herein, implants for astent graft, a valve, a mitral valve and associated system, apparatuses,and methods are shown and described.

As compared to other heart valves, in a diseased mitral valve, thetissue is relatively soft. This means that prior art self-expandingmitral implant valves which are oversized relative to the native mitralvalve continuously provide an outward expanding force to the nativemitral valve tissue. This force further expands the diseased tissuethroughout the life of the implant. Such a result is not desirable formany reasons, e.g., leakage, movement, and/or embolization. Providedherein in some exemplary embodiments are heart valve (e.g., mitralvalve) replacement implants that do not continuously provide anoutwardly directed force after implantation. These implants have aself-expansion aspect but that self-expansion occurs only for a certainextent—before or up to the native annulus of tissue surrounding themitral valve. After the self-expansion occurs, the adjustable stentlattice portion of the implant is then forcibly expanded into the nativeannulus only to an extent to seat the implant within the annulus with noleakage occurring around the implant. This means that, when a correctand sufficient implanted status occurs, there will be no additionaloutwardly directed force imparted on the native annulus by the implantto cause further outwards expansion of that tissue over the life of theimplant. This advantage over the prior art permits greater longevity.Also provided in some of the exemplary embodiments are optionalstructures that ensure a fluid-tight seal against each of the two sidesof the valve being replaced. One exemplary implant-securing structure isa self-expanding, implant skirt attached to the adjustable stentlattice, having a material that is fluid-tight or resistant (or afterbeing installed becomes fluid-tight), and, when released from thedelivery catheter, springing open to occlude the side of the valve onwhich it resides. It essentially is in the form of an umbrella thatcontacts the side of the implant site on its entire circumference.Another independent exemplary implant-securing structure is a set ofself-expanding, wall-retaining petals. These petals can be compressedwithin delivery wires while the implant is installed in the deliverycatheter, can continue to be held radially inwards by the deliverywires, while the implant is being maneuvered and installed in an implantsite, and spring open radially away from the central longitudinal axisof the implant when the delivery wires are released from the implantupon final deployment. In this way, the implant is adjustable andrepositionable repeatedly in both the expansion and contractiondirections up until final deployment. With both implant-securingstructures on opposing sides of the implant, the petals, the implantskirt, and the adjustable stent lattice form an annulus having a concaveU-shape that can entirely capture and hold therein the native valveannulus in a fluid-tight and leak-tight manner.

A further advantage of some of the embodiments of herein-describedmitral valve implants relates to the size of the valve portion when theimplant is secured in the native annulus. The native annulus of mitralvalves are substantially D-shaped. One characteristic of a diseasedmitral valve is that the annulus stretches outwardly, leaving theleaflets of the mitral valve unable to coapt and, thereby, impairing thefunctionality of the valve. In what is referred to as Mitral ValveProlapse, one or both of the valve flaps are enlarged and do not closein an even manner. With improper closure, blood could flow backwardsinto the left atrium, referred to as Mitral Valve Regurgitation. With astretching of the mitral valve annulus, even if a prior art implant isable to be secured therein, the size of that implant's valve opening maybe too large for the patient. Some of the embodiments of the mitralvalve implant herein provide a valve opening sized for optimal flowirrespective of the size of the diseased mitral valve annulus. Theseembodiments provide a fixed-sized valve opening contained within avariable outer annular skirt, the combined structures of the variablysized outer skirt and the fixed-sized valve being referred to herein asa trampoline valve. These exemplary implants, therefore, provide anideal amount of flow through the valve of the implant in spite of theenlarged native mitral valve annulus. This means that, regardless of thefinal D-shaped diameter of the implanted stent lattice, the trampolinevalve will have its own fixed maximum circular diameter, which improvesvalve function and durability. This feature allows a standard-sizedvalve to cover a large patient population with mitral valves of varioussizes. The skirt can optionally have a downstream flair that creates aback seal when high pressure of ventricle contraction is imparted.

With the foregoing and other objects in view, there is provided, amitral valve implant comprising a force-expanding mitral valve latticehaving an interior orifice and a self-expanding valve trampolineattached at the interior orifice of the force-expanding mitral valvelattice.

With the objects in view, there is also provided a mitral heart valveimplant system comprising a valve delivery system, a self-expanding andforcibly expanding mitral valve frame, a self-expanding implant skirt,wall-retaining wires, and a self-expanding valve trampoline lattice. Thevalve delivery system comprises a controller, a guidewire lumenconnected to the controller and having a distal nosecone, a hollowexternal sheath surrounding the guidewire lumen, having a proximal endconnected to the controller, and configured to retract proximally froman extended, valve-installed position, a given number of implant drivewires each having a distal drive wire connector, and hollow connectorlumens equal in number to the given number and each respectivelythreaded on one of the drive wires and having a distal hollow connectorsleeve. The self-expanding and forcibly expanding mitral valve framedefines a central axis and comprises proximal and distal jack screwstrut pairs equal in number to the given number and disposed parallel tothe central axis, intermediate struts equal in number to the givennumber and disposed parallel to the central axis, each intermediatestrut disposed between two adjacent ones of the jack screw strut pairs,arms respectively connecting adjacent ones of the jack screw strut pairsand the intermediate struts, and a plurality of jack screws. The jackscrews are each rotatably connected to one jack screw strut pair, form,together with the jack screw strut pairs, the intermediate struts, andthe arms, an adjustable stent lattice having a ventricle side and anatrial side, are configured to reversibly forcibly expand and contractthe adjustable stent lattice between a compressed state and an enlargedstate for implantation of the mitral valve frame into a native mitralvalve, and each have a driving connector shaped to removably mate andconnect to the distal drive wire connector of one of the drive wires andbe held connected thereto when the hollow connector sleeve is disposedabout the mated driving connector and distal drive wire connector suchthat rotation of the drive wires correspondingly rotates the jack screwsto forcibly expand or contract the adjustable stent lattice. Theself-expanding implant skirt is attached to the ventricle side of theadjustable stent lattice. The implant skirt is configured to compressand be stored inside the external sheath and, when released from theexternal sheath at a native mitral valve, to self-expand and sealablyposition on tissue at a ventricular side of the native mitral valve. Thewall-retaining wires are attached to the atrium side of the adjustablestent lattice and are configured to compress and be stored inside theexternal sheath and, when released from the external sheath at a nativemitral valve, to self-expand on tissue at an atrial side of the nativemitral valve. The self-expanding valve trampoline lattice is disposedinside and is connected to the adjustable stent lattice and comprises anexpandable outer trampoline portion having a circumferential exteriorconnected to the interior of the adjustable stent lattice and acircumferential interior and an inner circumferential valve portionconnected to the circumferential interior and extending inwardly fromthe circumferential interior to define an interior cylindrical portionand having a circular valve with internal valve leaflets disposed at theinterior cylindrical portion.

With the objects in view, there is also provided a mitral heart valveimplant system comprises a mitral valve lattice having a pre-setD-shaped cross-sectional configuration, defining an internal orifice,and comprising a plurality of jack screws configured to forcibly expandand contract the mitral valve lattice reversibly between a compressedconfiguration and an enlarged configuration, an outwardly flaring,self-expanding implant skirt attached to an exterior of the mitral valvelattice, the implant skirt shaped to be positioned on a ventricular sideof a native mitral valve to secure the mitral valve lattice in theannulus of the native mitral valve, radially outwardly biasedwall-retaining wires attached to the mitral valve lattice and shaped tobe positioned on an atrial side of the native mitral valve to secure themitral valve lattice in the annulus of the native mitral valve, aself-expanding valve trampoline lattice containing interior valveleaflets, the valve trampoline lattice disposed within the internalorifice of the mitral valve lattice and having a D-shape portionattached to the mitral valve lattice and a substantially cylindricalinterior portion, wherein the valve leaflets are attached to thesubstantially cylindrical interior portion, and a delivery systemcomprising a plurality of implant drive wires temporarily connectable tothe jack screws such that, when connected, rotation of the drive wiresin one direction forcibly expands the mitral valve lattice towards theenlarged configuration and rotation of the drive wires in a directionopposite the one direction forcibly contracts the mitral valve latticetowards the compressed configuration.

With the objects in view, there is also provided a method for implantinga mitral heart valve including the steps of contracting a self-expandingand forcibly-expanding mitral valve of a shape-memory material set to agiven shape to a reduced implantation size with a delivery system havingdrive wires, the mitral valve having an adjustable assembly withadjustable elements operatively connected to the drive wires such that,when the adjustable elements are adjusted by the drive wires, aconfiguration change in at least a portion of the mitral valve occurs,inserting the contracted mitral valve into a native mitral valve annulusin which the mitral valve is to be implanted, rotating the drive wireswith the delivery system to forcibly expand the mitral valve into thenative annulus, while rotating the drive wires, determining with thedelivery system a torque applied to the drive wires, and stoppingrotation of the drive wires based upon a value of the determined torque.

In accordance with another feature, the force-expanding mitral valvelattice is self-expandable to a first configuration and is forceexpandable from the first configuration to a second configuration.

In accordance with a further feature, the first configuration is one ofcircular and D-shaped.

In accordance with an added feature, the second configurationcorresponds in shape to the one of circular and D-shaped firstconfiguration.

In accordance with an additional feature, the mitral valve latticecomprises a plurality of jack screws configured to adjust expansion andcontraction of a configuration of the mitral valve lattice.

In accordance with yet another feature, the mitral valve lattice is madeof a shape memory material set shape to a given shape.

In accordance with yet a further feature, the valve trampoline has acylindrical central region comprising valve leaflets.

In accordance with yet an added feature, the valve trampoline comprisesa D-shaped portion.

In accordance with yet an additional feature, the valve leaflets have aninflow side and the D-shaped portion is located on an inflow side of thevalve leaflets.

In accordance with again another feature, the mitral valve lattice hasan exterior and there is provided an outwardly flaring implant skirtattached to the exterior of the mitral valve lattice and shaped to bepositioned on a side of a native mitral valve.

In accordance with again a further feature, there are providedwall-retaining wires attached to the mitral valve lattice and shaped tobe positioned on a side of the native mitral valve.

In accordance with again an added feature, the wall-retaining wires arein the shape of petals and have a pre-set, radially outward, memoryshape to impart a force on the side of the native mitral valve when themitral valve lattice is expanded within an annulus of the native mitralvalve.

In accordance with again an additional feature, the implant skirt is aleft ventricle implant skirt shaped to be positioned on a ventricularside of the native mitral valve when the mitral valve lattice isexpanded within the annulus of the native mitral valve and thewall-retaining wires are left-atrium wall-retaining wires shaped to bepositioned on an atrial side of the native mitral valve when the mitralvalve lattice is expanded within the annulus of the native mitral valve.

In accordance with still another feature, the implant skirt is a leftatrium implant skirt shaped to be positioned on an atrial side of thenative mitral valve when the mitral valve lattice is expanded within theannulus of the native mitral valve and the wall-retaining wires areleft-ventricle wall-retaining wires shaped to be positioned on aventricular side of the native mitral valve when the mitral valvelattice is expanded within the annulus of the native mitral valve.

In accordance with still a further feature, the mitral valve lattice hasan inlet end and an outlet end and the valve trampoline is attached tothe inlet end of the interior orifice.

In accordance with still an added feature, the mitral valve lattice hasan inlet end and an outlet end and the valve trampoline is attached tothe outlet end of the interior orifice.

In accordance with a concomitant feature, the adjustable stent latticehas a pre-set D-shaped cross-section and the exterior of the expandableouter trampoline portion is pre-set to a circumferential D-shape.

Although the systems, apparatuses, and methods are illustrated anddescribed herein as embodied in an actively controllable heart valveimplant and methods of controlling same, it is, nevertheless, notintended to be limited to the details shown because variousmodifications and structural changes may be made therein withoutdeparting from the spirit of the invention and within the scope andrange of equivalents of the claims. Additionally, well-known elements ofexemplary embodiments will not be described in detail or will be omittedso as not to obscure the relevant details of the systems, apparatuses,and methods.

Additional advantages and other features characteristic of the systems,apparatuses, and methods will be set forth in the detailed descriptionthat follows and may be apparent from the detailed description or may belearned by practice of exemplary embodiments. Still other advantages ofthe systems, apparatuses, and methods may be realized by any of theinstrumentalities, methods, or combinations particularly pointed out inthe claims.

Other features that are considered as characteristic for the systems,apparatuses, and methods are set forth in the appended claims. Asrequired, detailed embodiments of the systems, apparatuses, and methodsare disclosed herein; however, it is to be understood that the disclosedembodiments are merely exemplary of the systems, apparatuses, andmethods, which can be embodied in various forms. Therefore, specificstructural and functional details disclosed herein are not to beinterpreted as limiting, but merely as a basis for the claims and as arepresentative basis for teaching one of ordinary skill in the art tovariously employ the systems, apparatuses, and methods in virtually anyappropriately detailed structure. Further, the terms and phrases usedherein are not intended to be limiting; but rather, to provide anunderstandable description of the systems, apparatuses, and methods.While the specification concludes with claims defining the systems,apparatuses, and methods of the invention that are regarded as novel, itis believed that the systems, apparatuses, and methods will be betterunderstood from a consideration of the following description inconjunction with the drawing figures, in which like reference numeralsare carried forward.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying figures, where like reference numerals refer toidentical or functionally similar elements throughout the separateviews, which are not true to scale, and which, together with thedetailed description below, are incorporated in and form part of thespecification, serve to illustrate further various embodiments and toexplain various principles and advantages all in accordance with thesystems, apparatuses, and methods. Advantages of embodiments of thesystems, apparatuses, and methods will be apparent from the followingdetailed description of the exemplary embodiments thereof, whichdescription should be considered in conjunction with the accompanyingdrawings in which:

FIG. 1 is a fragmentary, side perspective view of an exemplaryembodiment of a distal end of a delivery and deployment system for anactively controllable heart valve implant;

FIG. 2 is a fragmentary, side perspective view of the distal end of thedelivery system of FIG. 1 with an exemplary embodiment of an activelycontrollable mitral valve replacement implant, with an implant skirt anda valve trampoline removed for clarity, in a pre-installationorientation with an outer catheter covering implant drive wires, withthe drive wires connected to jack screws of a self-expanding andforcibly-expanding valve lattice, with a self-expanding valve trampolinelattice containing non-illustrated valve leaflets within an orifice ofthe valve lattice and attached to the valve lattice;

FIG. 3 is a fragmentary, side perspective view of the distal end of thedelivery system of FIG. 1 with the mitral valve replacement implant ofFIG. 2 in a pre-installation orientation with the outer sheath retractedfrom the implant drive wires;

FIG. 4 is an enlarged, fragmentary, side perspective view of the distalend of the delivery system of FIG. 1 with the mitral valve replacementimplant of FIG. 3 in a pre-installation orientation with the mitralvalve implant in a self-expanded, enlarged state, with the implant skirtand the valve trampoline transparent;

FIG. 5 is a fragmentary, perspective view of the distal end of thedelivery system of FIG. 1 with the valve implant of FIG. 4 in apre-installation orientation with the valve implant in a forciblyexpanded, enlarged state;

FIG. 6 is a fragmentary, perspective view of the distal end of thedelivery system of FIG. 1 with the mitral valve replacement implant ofFIG. 5 in a fully-expanded, delivery orientation with the drive wiresstill engaged to the implant and constraining atrium wall retainers;

FIG. 7 is a fragmentary, perspective view of the distal end of thedelivery system of FIG. 1 with the mitral valve replacement implant ofFIG. 5 having the drive wires disengaged from the implant and from theatrium wall-retaining structures;

FIG. 8 is a fragmentary, perspective view of the distal end of thedelivery system of FIG. 1 with the mitral valve replacement implant ofFIG. 7 having the drive wires in a further retracted position from theimplant and with the nosecone in a retracted state within the implant;

FIG. 9 is a ventricle-side elevational view of the mitral valvereplacement implant of FIG. 8 with the mitral valve leaflets closed andwith the D-shape of the self-expanding valve trampoline lattice visible;

FIG. 10 is an atrium-side elevational view of the mitral valvereplacement implant of FIG. 8 with the valve leaflets in analmost-closed state;

FIG. 11 is a ventricle-side perspective view of the mitral valvereplacement implant of FIG. 9 with the valve leaflets partially open;

FIG. 12 is an atrium-side perspective view of the mitral valvereplacement implant of FIG. 9 with the valve in a substantially openstate;

FIG. 13 is a side elevational view of the mitral valve replacementimplant of FIG. 15 with attachment points connecting the skirt latticeand the skirt fabric to the adjustable stent lattice;

FIG. 14 is a fragmentary, perspective view of the delivery system ofFIG. 1 for the actively controllable mitral valve replacement implant ina vertical cross-section of a human heart and with the guidewire in theleft ventricle and the nosecone entering the left atrium of aventricle-contracted heart;

FIG. 15 is a fragmentary, perspective view of the delivery system ofFIG. 14 with the nosecone in the left ventricle of a ventricle-relaxedheart;

FIG. 16 is a fragmentary, perspective view of the delivery system ofFIG. 15 with the outer sheath withdrawn into the left atrium and themitral valve replacement implant beginning to show within aventricle-contracted heart;

FIG. 17 is a fragmentary, perspective view of the delivery system ofFIG. 16 with the outer sheath substantially withdrawn over the mitralvalve replacement implant and the implant skirt in a first self-expandedorientation within the mitral valve orifice of a ventricle-relaxedheart;

FIG. 18 is a fragmentary, perspective view of the delivery system ofFIG. 17 with the implant skirt in a second self-expanded orientationwithin the mitral valve orifice and with the drive wires of the mitralvalve replacement implant partially visible within aventricle-contracted heart;

FIG. 19 is a fragmentary, perspective view of the delivery system ofFIG. 18 with the implant skirt in a third self-expanded orientationwithin the mitral valve orifice and with the drive wires of the mitralvalve replacement implant visible within a ventricle-contracted heart;

FIG. 20 is a fragmentary, perspective view of the delivery system ofFIG. 19 with the adjustable stent lattice in a forcibly expandedorientation within the mitral valve orifice of a ventricle-relaxedheart;

FIG. 21 is a fragmentary, perspective view of the delivery system ofFIG. 20 with the adjustable stent lattice and the implant skirt in afully expanded and implanted orientation within the mitral valve orificeof a ventricle-contracted heart before disconnection of the drive wires;

FIG. 22 is a fragmentary, perspective view of an exemplary embodiment ofa sheath-constrained mitral valve replacement implant within a mitralvalve orifice viewed from the left atrium with the mitral valvepartially open, with the drive wires fully constraining the atriumretaining petals, and with the outer delivery sheath removed;

FIG. 23 is a fragmentary, perspective view of the sheath-constrainedmitral valve replacement implant of FIG. 22 with the mitral valve fullyopen;

FIG. 24 is a fragmentary, perspective view of the mitral valvereplacement implant of FIG. 23 with the sheath retracted and with theskirt of the mitral valve replacement implant in a self-expanded statewith the mitral valve fully open and with the drive wires constrainingthe atrium retaining petals;

FIG. 25 is a fragmentary, perspective view of the mitral valvereplacement implant of FIG. 24 with the mitral valve closed upon theskirt of the valve implant;

FIG. 26 is a fragmentary, perspective view of the mitral valvereplacement implant of FIG. 25 in a fully self-expanded state with themitral valve closed upon the mitral valve replacement implant;

FIG. 27 is a fragmentary, perspective view of the mitral valvereplacement implant of FIG. 26 in a forcibly expanded state with themitral valve partially open around the mitral valve replacement implantand with the replacement valve of the mitral valve replacement implantpartially open;

FIG. 28 is a fragmentary, perspective view of the mitral valvereplacement implant of FIG. 27 in still a further forcibly expandedstate with the mitral valve partially closed around the mitral valvereplacement implant and with the replacement valve of the mitral valvereplacement implant almost fully open;

FIG. 29 is a fragmentary, perspective view of the mitral valvereplacement implant of FIG. 28 in yet a further forcibly expanded statewith the mitral valve open around the mitral valve replacement implantand with the replacement valve of the mitral valve replacement implantfully open;

FIG. 30 is a fragmentary, perspective view of the mitral valvereplacement implant of FIG. 29 in another forcibly expanded state withthe mitral valve open around the mitral valve replacement implant andwith the replacement valve of the mitral valve replacement implantpartially open;

FIG. 31 is a fragmentary, perspective view of the mitral valvereplacement implant of FIG. 30 with the mitral valve closed around themitral valve replacement implant and with the replacement valve of themitral valve replacement implant closed around the delivery guidewirelumen;

FIG. 32 is a fragmentary, perspective view of the mitral valvereplacement implant of FIG. 31 held open by the mitral valve replacementimplant in a valve-implanted state and with the replacement valve of themitral valve replacement implant in an almost fully open state;

FIG. 33 is a fragmentary, perspective view of the mitral valvereplacement implant of FIG. 32 with the mitral valve replacement implantin the valve-implanted state and with the drive wire assembly retractedand disengaged to no longer constrain the atrium retaining petals;

FIG. 34 is a fragmentary, perspective view of the mitral valvereplacement implant of FIG. 33 with the mitral valve replacement implantin the valve-implanted state, with the drive wire assembly disengagedand further retracted, and with the atrium retaining petals retainedagainst the wall of the left atrium;

FIG. 35 is a fragmentary, perspective view of the mitral valvereplacement implant of FIG. 34 with the mitral valve replacement implantin the valve-implanted state, with the replacement valve of the mitralvalve replacement implant in an open state, and with the drive wireassembly completely retracted;

FIG. 36 is a fragmentary, perspective view of the mitral valvereplacement implant of FIGS. 9 to 13 in a skirt-and-valve-expanded stateapproximately equivalent to the view of the mitral valve replacementimplant of FIG. 26 and with the replacement valve in a substantiallyopen state;

FIG. 37 is a fragmentary, perspective view of the mitral valvereplacement implant of FIG. 36 in a skirt-and-valve-expanded stateapproximately equivalent to the view of the mitral valve replacementimplant of FIG. 27 and with the replacement valve in an almost closedstate;

FIG. 38 is a fragmentary, perspective view of the mitral valvereplacement implant of FIG. 37 in a skirt-and-valve-expanded stateapproximately equivalent to the view of the mitral valve replacementimplant of FIG. 29 and with the replacement valve in a partially openstate;

FIG. 39 is a fragmentary, perspective view of the mitral valvereplacement implant of FIG. 38 in a skirt-and-valve-expanded statebetween the views of the mitral valve replacement implant of FIGS. 31and 32 and with the replacement valve in a substantially closed state;

FIG. 40 is a fragmentary, perspective view of the mitral valvereplacement implant of FIG. 39 in a valve-implanted state approximatelyequivalent to the view of the mitral valve replacement implant of FIG.33 with the replacement valve in a substantially open state and with thedrive wires disengaged from the mitral valve replacement implant;

FIG. 41 is a fragmentary, perspective view of the mitral valvereplacement implant of FIG. 40 with the drive wires removed and with thenosecone partially retracted;

FIG. 42 is a fragmentary, perspective view of the mitral valvereplacement implant of FIG. 41 with the nosecone retracted partiallythrough and closed upon by the leaflets of the mitral valve replacementimplant;

FIG. 43 is a fragmentary, perspective view of the mitral valvereplacement implant of FIG. 42 with the nosecone withdrawn from themitral valve replacement implant and with the replacement valve in asubstantially open state;

FIG. 44 is a fragmentary, perspective view of an embodiment of anactively controllable delivery or deployment system for an adjustablestent graft;

FIG. 45 is a fragmentary, perspective view of another exemplaryembodiment of an actively controllable stent graft connected to thedelivery system of FIG. 44 in a partially expanded state;

FIG. 46 is a fragmentary, perspective view of the stent graft of FIG. 45in a fully expanded and ready-to-implant state;

FIG. 47 is a fragmentary, perspective view of the stent graft of FIG. 46implanted at a target area with tissue-engagement hooks deployed;

FIG. 48 is a fragmentary, vertically cross-sectional and perspectiveview of the delivery system of FIG. 44 inserted through the apex of theheart and through the mitral valve annulus into the left atrium;

FIG. 49 is a fragmentary, vertically cross-sectional and perspectiveview of the heart of FIG. 48 with the delivery system deploying thestent graft of FIG. 45 as a replacement mitral valve implant with theimplant partially expanded in the mitral valve annulus;

FIG. 50 is a fragmentary, horizontally cross-sectional and perspectiveview of the heart of FIG. 49;

FIG. 51 is a fragmentary, horizontally cross-sectional and perspectiveview of the heart of FIG. 49 with the delivery system having deployedhooks of the implant into the mitral valve annulus;

FIG. 52 is a fragmentary, horizontally cross-sectional and perspectiveview of the heart of FIG. 51 with the delivery system removed from theheart and the implant secured in the mitral valve annulus;

FIG. 53 is a fragmentary, perspective view of the actively controllabledelivery system of FIG. 44;

FIG. 54 is a fragmentary, perspective view of another exemplaryembodiment of an actively controllable heart valve replacement implantconnected to the delivery system of FIG. 53 in a partially expandedstate with the inner valve assembly removed;

FIG. 55 is a fragmentary, perspective view of the heart valvereplacement implant of FIG. 54 in a fully expanded and ready-to-implantstate with interior portions of the inner valve assembly removed;

FIG. 56 is a fragmentary, perspective view of the heart valvereplacement implant of FIG. 55 implanted at a target area withtissue-engagement hooks and a skirt deployed and with interior portionsof the inner valve assembly removed;

FIG. 57 is a fragmentary, top plan view of the heart valve replacementimplant of FIG. 56 implanted at a target area with tissue-engagementhooks and a skirt deployed and with interior portions of the inner valveassembly;

FIG. 58 is a fragmentary, vertically cross-sectional and perspectiveview of the delivery system of FIG. 44 inserted through the apex of theheart and through the mitral valve annulus into the left atrium;

FIG. 59 is a fragmentary, vertically cross-sectional and perspectiveview of the heart of FIG. 58 with the delivery system deploying thereplacement mitral valve implant of FIG. 57 with the implant partiallyexpanded in the mitral valve annulus;

FIG. 60 is a fragmentary, horizontally cross-sectional and perspectiveview of the heart of FIG. 59;

FIG. 61 is a fragmentary, horizontally cross-sectional and perspectiveview of the heart of FIG. 60 with the delivery system having deployedhooks of the implant into the mitral valve annulus;

FIG. 62 is a fragmentary, horizontally cross-sectional and perspectiveview of the heart of FIG. 61 with the delivery system removed from theheart and the implant secured in the mitral valve annulus;

FIG. 63 is a fragmentary, perspective view of the actively controllabledelivery system of FIG. 44;

FIG. 64 is a fragmentary, perspective view of another exemplaryembodiment of an actively controllable heart valve replacement implantconnected to the delivery system of FIG. 63 in a partially expandedstate with the inner valve assembly removed;

FIG. 65 is a fragmentary, perspective view of the heart valvereplacement implant of FIG. 64 in a fully expanded and ready-to-implantstate with interior portions of the inner valve assembly removed;

FIG. 66 is a fragmentary, perspective view of the heart valvereplacement implant of FIG. 65 implanted at a target area withtissue-engagement hooks and an upstream skirt deployed and with interiorportions of the inner valve assembly removed;

FIG. 67 is a fragmentary, top plan view of the heart valve replacementimplant of FIG. 66 implanted at a target area with tissue-engagementhooks, an upstream skirt, and a trampoline valve deployed and with valveleaflets removed;

FIG. 68 is a fragmentary, vertically cross-sectional and perspectiveview of the delivery system of FIG. 44 inserted through the apex of theheart and through the mitral valve annulus into the left atrium;

FIG. 69 is a fragmentary, vertically cross-sectional and perspectiveview of the heart of FIG. 68 with the delivery system deploying thereplacement mitral valve implant of FIG. 67 with the implant partiallyexpanded in the mitral valve annulus;

FIG. 70 is a fragmentary, horizontally cross-sectional and perspectiveview of the heart of FIG. 69 with the leaflets removed from the implant;

FIG. 71 is a fragmentary, horizontally cross-sectional and perspectiveview of the heart of FIG. 70 with the delivery system having deployedhooks of the implant into the mitral valve annulus;

FIG. 72 is a fragmentary, horizontally cross-sectional and perspectiveview of the heart of FIG. 71 with the delivery system removed from theheart and the implant secured in the mitral valve annulus;

FIG. 73 is an atrium-side elevational view of the mitral valvereplacement implant of FIGS. 64 to 67 and 69 to 72 with the valveleaflets in an almost-closed state and with hook fasteners extendedradially outward;

FIG. 74 is a top plan view of an implant skirt frame and an adjustablestent lattice of the mitral valve replacement implant of FIG. 73;

FIG. 75 is a perspective view from a side of the skirt frame andadjustable stent lattice of FIG. 74;

FIG. 76 is an atrium-side perspective view of another exemplaryembodiment of an actively controllable, mitral valve replacement implantwith an implant skirt, wall-retaining petals, and an internal valvetrampoline;

FIG. 77 is an atrium-side perspective view of an implant skirt frame,wall-retaining petals, a valve trampoline lattice, and an adjustablestent lattice of the mitral valve replacement implant of FIG. 76;

FIG. 78 is a substantially side elevational view of the mitral valvereplacement implant of FIG. 76;

FIG. 79 is a substantially side elevational view of the implant skirtframe, the wall-retaining petals, the valve trampoline lattice, and theadjustable stent lattice of the mitral valve replacement implant of FIG.76;

FIG. 80 is a ventricle-side perspective view of the mitral valvereplacement implant of FIG. 76;

FIG. 81 is a ventricle-side perspective view of the implant skirt frame,the wall-retaining petals, the valve trampoline lattice, and theadjustable stent lattice of the mitral valve replacement implant of FIG.76;

FIG. 82 is an installation-side perspective view of another exemplaryembodiment of an actively controllable, trampoline-side installed,circular valve replacement implant with an implant skirt, coveredopposing-side wall-retaining petals, and an internal valve trampoline;

FIG. 83 is an installation-side perspective view of an implant skirtframe, wall-retaining petals, a valve trampoline lattice, and anadjustable stent lattice of the circular valve replacement implant ofFIG. 82;

FIG. 84 is a substantially side elevational view of the circular valvereplacement implant of FIG. 82;

FIG. 85 is a substantially side elevational view of the implant skirtframe, the wall-retaining petals, the valve trampoline lattice, and theadjustable stent lattice of the circular valve replacement implant ofFIG. 82;

FIG. 86 is a nosecone-side perspective view of the circular valvereplacement implant of FIG. 82;

FIG. 87 is a nosecone-side perspective view of the implant skirt frame,the wall-retaining petals, the valve trampoline lattice, and theadjustable stent lattice of the circular valve replacement implant ofFIG. 82;

FIG. 88 is an installation-side perspective view of another exemplaryembodiment of an actively controllable, petal-side installed, circularvalve replacement implant with an implant skirt, opposing-sidewall-retaining petals, and an internal valve trampoline facing theimplant skirt;

FIG. 89 is an installation-side perspective view of an implant skirtframe, wall-retaining petals, a valve trampoline lattice, and anadjustable stent lattice of the circular valve replacement implant ofFIG. 88;

FIG. 90 is a substantially side elevational view of the circular valvereplacement implant of FIG. 88;

FIG. 91 is a substantially side elevational view of the implant skirtframe, the wall-retaining petals, the valve trampoline lattice, and theadjustable stent lattice of the circular valve replacement implant ofFIG. 88;

FIG. 92 is a nosecone-side perspective view of the circular valvereplacement implant of FIG. 88;

FIG. 93 is a nosecone-side perspective view of the implant skirt frame,the wall-retaining petals, the valve trampoline lattice, and theadjustable stent lattice of the circular valve replacement implant ofFIG. 88;

FIG. 94 is a nosecone-side perspective view of another exemplaryembodiment of an actively controllable, circular valve replacementimplant;

FIG. 95 is an installation-side perspective view of the circular valvereplacement implant of FIG. 94;

FIG. 96 is a nosecone-side perspective view of another exemplaryembodiment of an actively controllable, circular valve replacementimplant with a trampoline valve;

FIG. 97 is an installation-side perspective view of the circular valvereplacement implant of FIG. 96;

FIG. 98 is an installation-side perspective view of an adjustable stentlattice and valve trampoline lattice of the circular valve replacementimplant of FIG. 96;

FIG. 99 is a nosecone-side perspective view of the adjustable stentlattice the and valve trampoline lattice of FIG. 98;

FIG. 100 is a nosecone-side perspective view of another exemplaryembodiment of an actively controllable, circular valve replacementimplant with an installation-side implant skirt;

FIG. 101 is an installation-side perspective view of the circular valvereplacement implant of FIG. 100;

FIG. 102 is a side perspective view of an adjustable stent lattice andan implant skirt frame of the circular valve replacement implant of FIG.100;

FIG. 103 is a nosecone-side perspective view of another exemplaryembodiment of an actively controllable, circular valve replacementimplant with an installation-side implant skirt and a trampoline valve;and

FIG. 104 is an installation-side perspective view of the circular valvereplacement implant of FIG. 103.

DETAILED DESCRIPTION OF THE INVENTION

As required, detailed embodiments of the systems, apparatuses, andmethods are disclosed herein; however, it is to be understood that thedisclosed embodiments are merely exemplary of the systems, apparatuses,and methods, which can be embodied in various forms. Therefore, specificstructural and functional details disclosed herein are optional and notto be interpreted as limiting, but merely as a basis for the claims andas a representative basis for teaching one skilled in the art tovariously employ the systems, apparatuses, and methods in virtually anyappropriately detailed structure. Further, the terms and phrases usedherein are not intended to be limiting; but rather, to provide anunderstandable description of the systems, apparatuses, and methods.While the specification concludes with claims defining the features ofthe systems, apparatuses, and methods that are regarded as novel, it isbelieved that the systems, apparatuses, and methods will be betterunderstood from a consideration of the following description inconjunction with the drawing figures, in which like reference numeralsare carried forward.

In the following detailed description, reference is made to theaccompanying drawings which form a part hereof, and in which are shownby way of illustration embodiments that may be practiced. It is to beunderstood that other embodiments may be utilized and structural orlogical changes may be made without departing from the scope. Therefore,the following detailed description is not to be taken in a limitingsense, and the scope of embodiments is defined by the appended claimsand their equivalents.

Alternate embodiments may be devised without departing from the spiritor the scope of the invention. Additionally, well-known elements ofexemplary embodiments of the systems, apparatuses, and methods will notbe described in detail or will be omitted so as not to obscure therelevant details of the systems, apparatuses, and methods.

Before the systems, apparatuses, and methods are disclosed anddescribed, it is to be understood that the terminology used herein isfor the purpose of describing particular embodiments only and is notintended to be limiting. The terms “comprises,” “comprising,” or anyother variation thereof are intended to cover a non-exclusive inclusion,such that a process, method, article, or apparatus that comprises a listof elements does not include only those elements but may include otherelements not expressly listed or inherent to such process, method,article, or apparatus. An element proceeded by “comprises . . . a” doesnot, without more constraints, preclude the existence of additionalidentical elements in the process, method, article, or apparatus thatcomprises the element. The terms “including” and/or “having,” as usedherein, are defined as comprising (i.e., open language). The terms “a”or “an”, as used herein, are defined as one or more than one. The term“plurality,” as used herein, is defined as two or more than two. Theterm “another,” as used herein, is defined as at least a second or more.The description may use the terms “embodiment” or “embodiments,” whichmay each refer to one or more of the same or different embodiments.

The terms “coupled” and “connected,” along with their derivatives, maybe used. It should be understood that these terms are not intended assynonyms for each other. Rather, in particular embodiments, “connected”may be used to indicate that two or more elements are in direct physicalor electrical contact with each other. “Coupled” may mean that two ormore elements are in direct physical or electrical contact (e.g.,directly coupled). However, “coupled” may also mean that two or moreelements are not in direct contact with each other, but yet stillcooperate or interact with each other (e.g., indirectly coupled).

For the purposes of the description, a phrase in the form “A/B” or inthe form “A and/or B” or in the form “at least one of A and B” means(A), (B), or (A and B), where A and B are variables indicating aparticular object or attribute. When used, this phrase is intended toand is hereby defined as a choice of A or B or both A and B, which issimilar to the phrase “and/or”. Where more than two variables arepresent in such a phrase, this phrase is hereby defined as includingonly one of the variables, any one of the variables, any combination ofany of the variables, and all of the variables, for example, a phrase inthe form “at least one of A, B, and C” means (A), (B), (C), (A and B),(A and C), (B and C), or (A, B and C).

Relational terms such as first and second, top and bottom, and the likemay be used solely to distinguish one entity or action from anotherentity or action without necessarily requiring or implying any actualsuch relationship or order between such entities or actions. Thedescription may use perspective-based descriptions such as up/down,back/front, top/bottom, and proximal/distal. Such descriptions aremerely used to facilitate the discussion and are not intended torestrict the application of disclosed embodiments. Various operationsmay be described as multiple discrete operations in tum, in a mannerthat may be helpful in understanding embodiments; however, the order ofdescription should not be construed to imply that these operations areorder dependent.

Herein the relational terms “proximal” and “distal” are used. Meaningsfor these terms are to be determined in the context in which they areused. In various embodiments, where proximal and distal are used withregard to the delivery system and the implant to be deployed, the term“proximal” is in the direction towards the delivery handle and the userand away from the implant and term “distal” is in the direction awayfrom the delivery handle and the user and towards the implant.

As used herein, the term “about” or “approximately” applies to allnumeric values, whether or not explicitly indicated. These termsgenerally refer to a range of numbers that one of skill in the art wouldconsider equivalent to the recited values (i.e., having the samefunction or result). In many instances these terms may include numbersthat are rounded to the nearest significant figure. As used herein, theterms “substantial” and “substantially” means, when comparing variousparts to one another, that the parts being compared are equal to or areso close enough in dimension that one skill in the art would considerthe same. Substantial and substantially, as used herein, are not limitedto a single dimension and specifically include a range of values forthose parts being compared. The range of values, both above and below(e.g., “+/−” or greater/lesser or larger/smaller), includes a variancethat one skilled in the art would know to be a reasonable tolerance forthe parts mentioned.

It will be appreciated that embodiments of the systems, apparatuses, andmethods described herein may be comprised of one or more conventionalprocessors and unique stored program instructions that control the oneor more processors to implement, in conjunction with certainnon-processor circuits and other elements, some, most, or all of thefunctions of the devices and methods described herein. The non-processorcircuits may include, but are not limited to, signal drivers, clockcircuits, power source circuits, and user input and output elements.Alternatively, some or all functions could be implemented by a statemachine that has no stored program instructions, or in one or moreapplication specific integrated circuits (ASICs) or field-programmablegate arrays (FPGA), in which each function or some combinations ofcertain of the functions are implemented as custom logic. Of course, acombination of these approaches could also be used. Thus, methods andmeans for these functions have been described herein.

The terms “program,” “software,” “software application,” and the like asused herein, are defined as a sequence of instructions designed forexecution on a computer system or programmable device. A “program,”“software,” “application,” “computer program,” or “software application”may include a subroutine, a function, a procedure, an object method, anobject implementation, an executable application, an applet, a servlet,a source code, an object code, any computer language logic, a sharedlibrary/dynamic load library and/or other sequence of instructionsdesigned for execution on a computer system.

Herein various embodiments of the systems, apparatuses, and methods aredescribed. In many of the different embodiments, features are similarTherefore, to avoid redundancy, repetitive description of these similarfeatures may not be made in some circumstances. It shall be understood,however, that description of a first-appearing feature applies to thelater described similar feature and each respective description,therefore, is to be incorporated therein without such repetition.

Described now are exemplary embodiments of the present invention.Referring now to the figures of the drawings in detail and first,particularly to FIGS. 1 to 13, there is shown a first exemplaryembodiment of an actively controllable delivery and deployment system100, for example, for an actively controllable mitral heart valvereplacement implant 200. The delivery system 100 includes an innerelongate member that comprises a guidewire lumen 110, a nosecone 120disposed at the distal end of the guidewire lumen 110, a hollow exteriorsheath 130 surrounding the guidewire lumen 110 and shaped to smoothlyconnect to the proximal end of the nosecone 120, and a non-illustrateddelivery and deployment handle connected to the guidewire lumen 110, tothe exterior sheath 130, and to implant controls that are described infurther detail below. The sheath-nosecone connection is established byforming the proximal end of the nosecone 120 with a taper 122 that endswith an abutting wall 124 at the proximal most end of the distalnosecone taper 126. The distal taper 126 has an outer diameter at thewall 124 that is substantially equal to the outer diameter of the distalend of the sheath 130 and the wall 124 has a height that issubstantially equal to the thickness of the material of the hollowsheath 130.

The actively controllable mitral heart valve replacement implant 200 is,in FIG. 1, compressed within the sheath 130 and surrounding theguidewire lumen 110, as can be seen in FIG. 2, in which the sheath 130has been retracted proximally to such an extent that the implant 200 canbe seen in its entire longitudinal extent. Even though the implant 200should be expanded further than the configuration shown in FIG. 2 whenit is fully exposed from the sheath 130, the implant 200 is depicted inFIG. 2 in only a slightly expanded orientation as compared to thecompletely encased and compressed orientation of the non-visible implant200 in FIG. 1.

The implant 200 has an external, adjustable stent lattice 210. The stentlattice 210 can be of a shape memory material (such as nitinol, forexample). The adjustable stent lattice 210 is set to a pre-determinedshape that, in this exemplary mitral valve embodiment, is D-shaped asshown in FIG. 5 and, particularly, in FIGS. 9 to 12. (In an alternativeexemplary embodiment where the implant site is circular, the adjustablestent lattice would be pre-set to a circular shape.) Connected to theinterior of the adjustable stent lattice 210 is a self-expanding valvetrampoline lattice 230. The trampoline lattice 230 can be integral withthe adjustable stent lattice 210 or fixedly connected thereto, forexample, by crimping, banding, welding. A set of hollow disconnectlumens 140 surround lattice drive wires 150 and both are operativelyconnected to a non-illustrated delivery and deployment handle (alsoreferred to as a controller because it need not be shaped as a handle).The exemplary embodiment of the disconnect lumens 140 are tubes thatextend from the handle to the implant 200 and each surround a drive wire150. Lattice disconnect tubes 142 are respectively disposed at the endof each hollow disconnect lumens 140. The lattice disconnect tubes 142are rotationally fixed to the disconnect lumens 140 such that, when thedisconnect lumen 140 rotates, the respective lattice disconnect tube 142rotates correspondingly. The lattice disconnect tubes 142 surround thedistal end of the drive wires 150, at which distal end are drive wireconnectors 152. The drive wire connectors 152 are each shaped to connectto respective proximal ends of jack screws 220 that are rotatablyconnected to the adjustable stent lattice 210 as described in furtherdetail below.

FIG. 2 depicts the implant 200 without an implant skirt and a valvetrampoline (which are removed for clarity but are shown in FIG. 4). Theimplant 200 is in a pre-installation orientation before the drive wires150 have caused the jack screws 220 to expand the adjustable stentlattice 210. The lattice disconnect tubes 142 at each distal end of thedisconnect lumens 140 are partially visible from under the outer sheath130. Under the lattice disconnect tubes 142, the drive wires 150 areremovably connected to the proximal end of each jack screw 220 so that,as long as the lattice disconnect tubes 142 remain in this distallydisposed state adjacent the proximal end of the adjustable stent lattice210, the drive wires 150 are rotationally fixed to the proximal end ofeach jack screw 220, which means that, as a drive wire 150 rotates, therespective jack screw 220 rotates correspondingly. The non-illustrateddelivery and deployment handle controls expansion and contraction of theadjustable stent lattice 210 and deployment of the implant 200 byrotation of the drive wires 150 and, when deployment is desired, byproximal movement of the disconnect lumens 140, which, when movedproximally, translate the lattice disconnect tubes 142 away from theconnection between the drive wires 150 and the expansion/contractionassembly of the adjustable stent lattice 210 (see jack screws below) topermit automatic separation of the drive wires 150 and the jack screws.

The self-expanding valve trampoline lattice 230 is disposed within acentral orifice of the adjustable stent lattice 210 and is attached tothe adjustable stent lattice 210. FIG. 3 shows the sheath 130 entirelyremoved from the implant 200 and the lattice disconnect tubes 142. Here,the adjustable stent lattice 210 is further expanded towards itspre-defined self-expanding shape. Visible in FIG. 3 is the connectionlocation of the drive wire connectors 152 and the proximal end of thejack screws 220, but that connection is hidden within the respectivelattice disconnect tubes 142.

FIG. 4 illustrates the implant 200 in approximately its fullyself-expanded state. The exterior implant skirt 240 and the valvetrampoline lattice 230 are shown but are transparent in this figure. Aswill be explained in further detail below, the implant skirt 240 isattached (e.g., with sutures in the shape of an “X”) to the exteriorsurfaces of the adjustable stent lattice 210.

FIG. 5 illustrates the implant 200 in a partially forcibly expandedstate and FIG. 6 illustrates the implant 200 in a further expandedstate. The implant 200 is rotated in FIG. 6 to show more of the leftventricle side of the implant, i.e., the side of the implant configuredto be positioned with the left ventricle of the patient. Here, theexterior implant skirt 240 and the valve trampoline lattice 230 arefully resolved and, therefore, the implant skirt 240 covers theadjustable stent lattice 210 so that it is no longer visible. Theself-expanding, memory shaped skirt lattice 242 is visible beneath theexterior material 244 of the implant skirt 240 for clarity. The material244 can be made from anything that is fluid-tight or resistant andretains that fluid-tight or resistant characteristic even after beingattached to the skirt lattice 242 or to the adjustable stent lattice 210with sutures that puncture the material 244, for example. The material244 can be a woven polyester fabric, a sheet of plastic, and/or a sheetof pericardial tissue, for example. Preferably, the material 244 is ofbraided polyester coated with polyurethane. As can be seen on theexterior surface of the material 244, sutures 246 (e.g., in the shape ofan “X”) fixedly attach the material 244 and the skirt lattice 242 to theadjustable stent lattice 210 therein such that, as the adjustable stentlattice 210 expands, both the skirt lattice 242 and the material 244expands correspondingly, as is shown, for example, in the transitionfrom FIG. 5 to FIG. 6.

Extending proximally from skirt lattice 242 (and being part of the skirtlattice 242) are left-atrium wall-retaining petals 248. Even though thematerial 244 prevents viewing of the entire extent of the retainingpetals 248, it can be seen in FIGS. 5 and 6 that the lattice disconnecttubes 142 are disposed radially outside the retaining petals 248 butinside the skirt lattice 242/material 244. In this manner, the petals248 are prevented from expanding radially outwards until the latticedisconnect tubes 142 are disconnected from the adjustable stent lattice210. FIG. 6 shows the implant 200 in an exemplary fully-expanded,delivery orientation with the drive wires 150 still engaged to theimplant 200. It is noted that the circular shape of the retaining petals248 is only one exemplary configuration for retaining the implant 200 onthe atrium side of the mitral valve annulus. These petals 248 can takeany shape that, after being allowed to pivot in a direction from theguidewire lumen 110 radially outward, allows the implant 200 to besecured on the atrium side.

When the implant 200 is positioned in a final desired orientation, suchas that shown in FIGS. 7 through 13, the drive wires 150 are to bedisconnected from all of the jack screws 220 and, thereafter, removedfrom the patient. To disengage the drive wires 150, a non-illustratedcontrol handle moves each of the disconnect lumens 140 proximally(either simultaneously or separately) to thereby slide the hollowdisconnect tubes 142 away from the adjustable stent lattice 210. Whenthis covering is removed, the temporary connection of the drive wireconnectors 152 and the proximal ends of the jack screws 220 can beallowed to separate from one another, as shown in FIG. 7, allowing thedisconnect lumens 140 and the drive wires 150 (and the sheath 130 ifdesired) to retract away from the adjustable stent lattice 210. Thecollapsed or contracted state of the wall-retaining petals 248 onlyremains while the disconnect lumens 140 and the drive wires 150 remainconnected to the adjustable stent lattice 210. When disconnectedtherefrom, the petals 248 are allowed to move to their steady state orpre-set orientation, which is a position where the petals 248 extend ina plane that is substantially perpendicular to the axis of the guidewirelumen 110. Likewise, when allowed to self-expand, the skirt lattice 242moves to its steady-state or pre-set orientation, which is a positionwhere the edges of the skirt lattice 242 extend in a plane that is moreperpendicular to the axis of the guidewire lumen 110 than parallelthereto. This orientation of the implant 200 secured in a targetlocation, such as the mitral valve annulus, is depicted in the views ofFIGS. 9 to 12 and, in particular, in the side elevational view of FIG.13. As can be seen in FIG. 13, the angle α between the petals 248 andthe central axis 202 of the implant 200 is between approximately 45degrees and approximately 90 degrees including every numbertherebetween. In particular, the angle α is between approximately 50degrees and approximately 75 degrees including every numbertherebetween.

Also shown in FIGS. 5 to 13 is the structure of the valve trampolinelattice 230, including a centrally disposed valve 250, which, in thisexemplary embodiment, is a replacement for a mitral valve. Moreparticularly, as shown in FIG. 5, the self-expanding valve trampolinelattice 230 has an expandable outer trampoline portion 232 and anexpandable but fixed maximum diameter inner circumferential valveportion 234, which can be cylindrical and, for example, fabricated froma laser-cut, nitinol tube. The outer trampoline portion 232 connects onits exterior circumference to an interior circumference of theadjustable stent lattice 210. The connection can be integral or can beformed, for example, by crimping, banding, and/or welding. Deformablecells of the outer trampoline portion 232 allow the outer trampolineportion 232 to expand and contract substantially. In this example, thecells are substantially marquis-shaped or tear-drop shaped, but they cantake other closed curved or straight shapes. More particularly in theexemplary embodiment of FIGS. 5 to 13, the valve trampoline lattice 230has figure-eight-shaped structures that, when attached together at theirsides, form five rows of cells that circumscribe the valve trampolinelattice. The outer trampoline portion 232 includes the first four rowsof tear-drop and marquis-shaped cells. A first row of relatively smallertear-drop-shaped cells 232 a (see FIGS. 7 and 8) are sixteen in numberand define an outermost ring of outer trampoline portion 232 cells. Asecond row of relatively larger marquis-shaped cells 232 b, also sixteenin number, define a first inner ring of the outer trampoline portion232. A third row of sixteen marquis-shaped cells 232 c narrower andlonger than the cells 232 b define a second inner ring of the outertrampoline portion 232. Finally, a fourth row of sixteen smallestmarquis-shaped cells 232 d define a third inner ring of the outertrampoline portion 232. In comparison, the inner circumferential valveportion 234 of the valve trampoline lattice 230 has one row of sixteencells 234 a about its circumference, each cell having a longitudinallength that is about the same as the circumferential width. Accordingly,these sixteen cells 234 a are substantially circular, even though theyhave tear-drop tips on either end. The substantially circular nature ofthe sixteen cells 234 a creates a cylinder at the interior end of thevalve trampoline lattice 230. This compound structure allows the innercircumferential valve portion 234 to remain substantially circular evenwhile the outer trampoline portion 232 expands and contracts withexpansion or contraction of the adjustable stent lattice 210.

Accordingly, when the adjustable stent lattice 210 expands or contracts,the outer circumference of the outer trampoline portion 232correspondingly expands or contracts without limitation. The innercircumferential valve portion 234 connects to the outer trampolineportion 232 at cell connection points 233. This inner circumferentialvalve portion 234 is not D-shaped and does not have cells that allow itto expand and contract in the same way that the cells of the outertrampoline portion 232 permit unrestricted expansion. Instead, in thisexemplary configuration, the cells of the inner circumferential valveportion 234 only allow expansion up to a pre-determined state once theadjustable stent lattice 210 is expanded far enough to no longerconstrain the inner circumferential valve portion 234. At that state,which is shown starting at FIG. 6, the cells forming the outercircumference of the inner circumferential valve portion 234 aredisposed about the central axis 202 of the implant 200 in asubstantially circular manner defining a pre-determined maximum diameterD, shown in FIGS. 7 and 8 and continues in FIGS. 9 to 13. Thus, nomatter how far the adjustable stent lattice 210 expands the outertrampoline portion 232 of the trampoline lattice 230, the innercircumferential valve portion 234 will not expand past the diameter D.

The reason why the trampoline lattice 230 is referred to as a“trampoline” is because of the way that it supports the valve 250. Atthe inner circumferential valve portion 234, the trampoline lattice 230is substantially constant after the adjustable stent lattice 210 hasexpanded to no longer restrict the inner circumferential valve portion234. The outer trampoline portion 232, in contrast, expands to whatevershape is needed to bridge the gap between the inner circumferentialvalve portion 234 and the adjustable stent lattice 210. Thus, the outerportion 232 acts as a stretchable “trampoline” to move and adjust towhatever shape is needed to suspend the relatively stable innercircumferential valve portion 234 (and the valve 250) at the centralregion of the trampoline lattice 230. The natural shape of the outertrampoline portion 232 corresponds to the inner circumference of theadjustable stent lattice 210, which means it has a natural D-shapedcircumference.

Both the outer trampoline portion 232 and the inner circumferentialvalve portion 234 are fluid-tightly sealed to the material 244 so that,when installed, the implant 200 forms a fluid-tight seal that onlypermits fluid flow through the valve 250. As shown best in FIGS. 9 and10, a first sealing material 235 is secured to the inside surfaces ofthe outer trampoline portion 232 and a second sealing valve material 237is secured to the inside surfaces of the inner circumferential valveportion 234. The second sealing valve material 237 can be a single sheetwith three leaflets cut therein or it can be a set of three separateleaflet portions individually connected to the interior surfaces of theinner circumferential valve portion 234. The material 235 can be a wovenpolyester fabric, a sheet of plastic, and/or a sheet of pericardialtissue, for example. The material 237 can be pericardial tissue or anatural valve harvested from a mammal, such as a porcine valve. In thisexemplary embodiment, the second sealing valve material 237 extends fromthe distal most ends of the inner circumferential valve portion 234 tothe center of the valve 250 and, thereby, forms the leaflets 252 of thevalve 250, which, in this embodiment, is a tricuspid form (i.e., threeleaflets 252). The tricuspid form is not to be considered as limitingand can have any number of leaflets. The first sealing material 235 andthe second sealing valve material 237 can be separate, with the leaflets252 extending into the central orifice of the inner circumferentialvalve portion 234 from either the first or second materials 235, 237, orthey can be integral, with the leaflets 252 being a part of the materialportions 235, 237 and extending into the central orifice of the innercircumferential valve portion 234.

With the petals 248 on the atrium side of the now-installed implant 200and the skirt lattice 242 with its material 244 on the ventricle side ofthe implant 200, the diseased mitral valve annulus is captured andsurrounded by the implant 200 in a liquid-tight and leak-free manner.Viewed in a cross-sectional plane extending along the axis of theguidewire lumen 110, therefore, the petals 248 and the skirts lattice242 with the material 244 forms a U-shaped annular raceway as depictedin FIG. 13.

This capture of the native mitral valve annulus is depicted in theprogression of FIGS. 14 to 22, which is an example of replacement mitralvalve implantation with a transapical approach. In FIG. 14, a guidewire10 has been installed through the atrium wall and the diseased mitralvalve 12 and rests in the left ventricle. The guidewire lumen 110 isthreaded onto the guidewire 10 and the guidewire lumen 110 enters theleft atrium preceded by the distally connected nosecone 120. Thenosecone 120 of the delivery system 100 is extended into the leftventricle in FIG. 15. In FIG. 16, the outer sheath 130 has beenwithdrawn into the left atrium and the mitral valve replacement implant200 contained within the sheath 130 starts to be exposed within thediseased mitral valve annulus. In FIG. 17, the outer sheath 130 has beenwithdrawn almost all of the way over the mitral valve replacementimplant 200 to an extent where the implant skirt 240 is able toself-expand into and towards the sub-valvular structures below thediseased mitral valve annulus. In FIG. 18, the outer sheath 130 has beenwithdrawn completely from the mitral valve replacement implant 200 to anextent where the sheath 130 only constrains the disconnect lumens 140and drive wires 150. The implant skirt 240 is further self-expanded intothe sub-valvular structures below the diseased mitral valve annulus. InFIG. 19, the outer sheath 130 has been withdrawn completely to no longerradially constrain the disconnect lumens 140 or drive wires 150 to,thereby, allow the adjustable stent lattice 210 to self-expand to itspre-determined, memory shape. The implant skirt 240 is furtherself-expanded into and touching the sub-valvular structures below thediseased mitral valve annulus to an extent that it could reach and touchthe chords beyond the native leaflet edges if sized appropriately. FIG.20 shows the adjustable stent lattice 210 forcibly expanded radiallyoutwards and the implant skirt 240 remaining secured against thesub-valvular structures below the diseased mitral valve annulus but alsoadapting to the forcibly expanded orientation of the internal adjustablestent lattice 210. Finally, FIG. 21 illustrates the mitral valvereplacement implant 200 in a fully expanded and implanted orientationwithin the mitral valve annulus just before disconnection of the drivewires 150. As can be seen, the implant skirt 240 substantially engagesthe native leaflets 14 and chordae tendineae 16 to create a fluid tightseal at the mitral valve annulus.

The process for installing the implant 240 from the atrial side is shownin the progression of FIGS. 22 through 35. FIGS. 22 and 23 illustratethe guidewire 10 resting in the left ventricle (installed through theatrium wall) and the diseased mitral valve 12. The guidewire lumen 110is threaded onto the guidewire 10 and enters the left atrium preceded bythe distally connected nosecone 120, resting in the left ventricle. Themitral valve 12 is shown partially closed in FIG. 22 and substantiallyopen in FIG. 23. The implant 200 is compressed within the exteriorsheath 130 but the sheath 130 is not illustrated for clarity. In FIG.24, the outer sheath 130 has been retracted to allow the implant 240 tostart self-expanding to its pre-defined, mitral valve D-shape and theimplant skirt 240 to start self-expanding within the ventricle to itspre-defined memory shape. In this figure, the mitral valve 12 issubstantially open. The adjustable stent lattice 210 is positionedwithin the mitral valve annulus, as can be seen in FIG. 25, where themitral valve 12 is closed upon the adjustable stent lattice 210. As thedrive wires 150 and disconnect lumens 140 are still connected to theadjustable stent lattice 210, the atrium wall-retaining petals 248 areconstrained at the interior sides of the disconnect lumens 140. With theimplant 200 centrally disposed within the mitral valve 12, the drivewires 150 can be rotated to actuate the jack screws 220 and, thereby,start expansion of the implant 200. FIG. 26 shows the implant 200 in thestate where the implant 200 is fully self-expanded and defines thepre-defined D-shape of the implant (albeit smaller than when implanted),and FIG. 27 shows the implant 200 in a first, forcibly expanded state,with the D-shape larger than the pre-set D-shape. With the mitral valve12 partially open around the implant 200, the implant skirt 240 can beseen on the ventricle side self-expanded to such an extent that italready occludes the opening of the mitral valve 12, which is due bothto the self-expanding features of the implant skirt 240, 242, 244 and tothe pressure exerted on the ventricle side of the implant skirt 240 byblood flow. Likewise, this blood flow imparts a force on the replacementvalve 250, causing the leaflets 252 to open and allow blood flow throughthe implant 200. With still further expansion of the implant 200, asshown in FIGS. 28 and 29, expansion of the outer trampoline portion 232becomes more apparent and the replacement valve 250 begins to functionas a valve well before full implantation occurs. This valve functioningis clearly shown in FIGS. 30 and 31, in which, a further expanded stateof the implant 200 allows the leaflets 252 of the replacement valve 250to fully open and fully close (about the guidewire lumen 110).

When the implant 200 has been expanded to a state where it is fixed inthe diseased mitral valve 12 to hold the diseased mitral valve 12 open,as shown in FIG. 32, the implant 200 is ready to be disengaged from thedelivery system 100. At this point, the surgeon can ensure correctimplantation because the implant 200 has the ability to reversiblycontract and be repositioned if desired. To confirm that the implant 200is in a desired final state, the surgeon can inject a contrast dye intothe ventricle (e.g., through the guidewire lumen 110 or through theguidewire 10, if either is configured to deliver dye, or through aseparate contrast device within the ventricle). When the surgeon hasdetermined that no leakage occurs around the implant 200 and that theimplant 200 is satisfactorily installed, the surgeon can actuate thedisengagement feature of the delivery system 100, which, in thisexemplary embodiment, causes the disconnect lumens 140 to retractproximally and, thereby, move the lattice disconnect tubes 142 away fromthe drive wire connectors 152. FIG. 33 illustrates the disconnect lumens140 having retracted the lattice disconnect tubes 142 from the drivewires 150 to expose the drive wire connectors 152 (which engage theproximal ends of the jack screws 220 and remain engaged only so long asthe lattice disconnect tubes 142 are extended) and, thereby, allow thedrive wire connectors 152 to disengage automatically from the jackscrews 220. At this point, implantation is final and cannot be reversedwithout physically removing the implant 200, e.g., through a secondaryopen surgical procedure. However, such a situation is not necessary whenthe surgeon has ensured correct placement before disengagement.

Now that the disconnect lumens 140 and lattice disconnect tubes 142 nolonger restrain the atrium wall-retaining petals 248, the petals 248 canexpand outward to their pre-set orientation. FIG. 33 shows the petals248 in the process of this expansion and FIG. 34 illustrates the petals248 fully expanded and compressing the ventricle side of the mitralvalve 12 in a direction of the implant skirt 240, which, itself, isfully expanded and imparting a compressive force against the atrium sideof the mitral valve 12. As the implant process is complete, thedisconnect lumens 140 and the drive wires 150 can be removed, which isdepicted in FIG. 35.

Above, the implant skirt 240 is described as self-expanding on theventricle side of the mitral valve 12 starting from the time that it isreleased from capture within the exterior sheath 130. That expansion isshown from a side of the implant 240 in FIGS. 18 through 21, 24, and 27.FIGS. 36 through 43, however, show the behavior of the implant skirt 240as the adjustable stent lattice 210 is forcibly expanded from its fullyself-expanded state (shown in FIG. 36) until the time of finalimplantation (shown in FIG. 40). FIGS. 36 through 43 show this behaviorviewed from the ventricle side of the implant 200. As the adjustablestent lattice 210 forcibly expands from its self-expanded state in FIG.36 through the range of expansion in FIGS. 37, 38, and 39, it can beseen that the innermost portions of the implant skirt 240, including theskirt lattice 242 and the outer material 244, move and adjust toaccommodate the ever-expanding outer extremities of the outer trampolineportion 232. In contrast, the outermost annulus of the implant skirt 240remains substantially constant from the time that it is completelyreleased from the sheath 130 until the time when the implant 200 is inits final implant orientation, which is seen in FIG. 40. At this point,the stent control devices (disconnect lumens 140 and drive wires 150)can be disconnected and withdrawn, which is depicted in FIG. 40, thesedevices 140, 150 being entirely removed from view in FIG. 41 and thenosecone 120 being withdrawn in the progression of FIG. 42 to FIG. 43.These figures illustrated that the replacement valve 250 has functioningleaflets 252 from the time that the adjustable stent lattice 210 ismerely allowed to self-expand and continues functioning as a valve allduring the time that the implant 200 is being adjusted, expanded,contracted, moved, and/or rotated. These figures also show how the valvetrampoline lattice acts as a trampoline. The inner circumferential valveportion 234 remains patent in its circular orientation throughout thetime that the outer trampoline portion 232 is being expanded (orcontracted).

FIGS. 44 to 47 illustrate an alternative embodiment of an activelycontrollable stent graft 300. This implant is similar in structure tothe implant 200 except the wall-retaining petals 248 and the exteriorimplant skirt 240 are not present. Although the interior valve assemblyalso is not present, any valve assembly can be included within theadjustable stent lattice 310 of the implant 300. The implant 300 can besubstantially circular or it can be D-shaped. As all other aspects ofthe implant 300 are similar to the implant 200, all features are notrepeated to avoid unnecessary repetition. Likewise, where similar partsare referenced, the reference numeral is increased by 100. What isdifferent with the implant 300 is that the tissue-fixation structuresare extendible hooks 342 that are part of or attached to the adjustablestent lattice 310. Such hooks 342 can take the form of the needles 1700or 2200 or 3070 shown and described in U.S. Patent Publication No.2013/0046373 to Cartledge et al.

Deployment of the implant 300 is performed just as implant 200. Thedelivery system 100 in FIG. 44 is guided along a non-illustratedguidewire to an implant site in the patient. The adjustable stentlattice 310 is allowed to self-expand after removal of the sheath 130and then is forcibly expanded into the annulus of the implant site to afinal implant size, the implant 300 being reversibly expanded andcontracted as desired to achieve optimal deployment. This expansion isshown in FIGS. 45 and 46 (the graft material 335 of the implant 300 isnot illustrated in FIG. 45). When the implant 300 is in the desiredlocation and orientation and is ready to be released, the extendiblehooks 342 are extended out from the sides of the implant 300 to enterinto and fixedly connect to the tissue at the implant site. Only threeof the hooks 342 are illustrated in FIG. 47 but this number is not to belimiting. In an exemplary embodiment, the number of hooks 342 is equalto the number of disconnect lumens 140, which in the embodiment shownwould be six in number.

FIGS. 48 to 52 illustrate the process for deploying the implant 300, forexample, in the mitral valve of a heart. In contrast to the embodimentof implant 200, which is inserted through the atrium from above theheart, the implant 300 is inserted through a transapical approach. Thedelivery system 100 is inserted through the apex of the heart up throughthe left ventricle and through the mitral valve 12 to place the nosecone120 within the left atrium. The implant 300 is expanded into the mitralvalve 12 as shown in FIGS. 49 and 50. When ready to implant, the hooks342 are extended into the wall of the heart. In FIG. 52, the implant 300is released from the delivery system 100 and the internal valve leafletsfunction to valve the blood flow.

FIGS. 53 to 57 illustrate an alternative embodiment of an activelycontrollable replacement mitral valve implant 400. This implant issimilar in structure to the implant 200 except the wall-retaining petals248 are not present Like implant 200, the implant 400 has an exteriorimplant skirt 440. The implant 400 can be substantially circular, but itis D-shaped in this mitral valve embodiment. As all other aspects of theimplant 400 are similar to the implant 200, all features are notrepeated to avoid unnecessary repetition. Likewise, where similar partsare referenced, the reference numeral is increased by 200. What isdifferent with the implant 400 is that the implant skirt 440 issupplemented with tissue-fixation structures in the form of extendiblehooks 442 that are part of or attached to the adjustable stent lattice410. Such hooks 442 can take the form of the needles 1700 or 2200 or3070 shown and described in U.S. Patent Publication No. 2013/0046373 toCartledge et al.

Deployment of the implant 400 is performed just as implant 200. Thedelivery system 100 in FIG. 53 is guided along a non-illustratedguidewire to an implant site in the patient. The adjustable stentlattice 410 is allowed to self-expand after the sheath is removed andthen is forcibly expanded into the annulus of the mitral valve to afinal implant size, the implant 400 being reversibly expanded andcontracted as desired to achieve optimal deployment. As with implant200, when the sheath 130 is removed from the compressed implant 400, theimplant skirt 440 is allowed to self-expand on the ventricle side of themitral valve annulus. This expansion is shown in FIGS. 54 and 55 (thegraft material 435 of the implant 400 is not illustrated in FIG. 54).When the implant 400 is in the desired location and orientation and isready to be released, the extendible hooks 442 are extended out from thesides of the implant 400 to enter into and fixedly connect to the tissueat the implant site. Only three of the hooks 442 are illustrated in FIG.56 but this number is not to be limiting. In an exemplary embodiment,the number of hooks 442 is equal to the number of disconnect lumens 140,which in the embodiment shown would be six in number.

FIGS. 58 to 62 illustrate the process for deploying the implant 400 inthe mitral valve annulus of a heart. In contrast to the embodiment ofimplant 200, which is inserted through the atrium from above the heart,the implant 400 is inserted through a transapical approach. The deliverysystem 100 is inserted through the apex of the heart up through the leftventricle and through the mitral valve 12 to place the nosecone 120within the left atrium. The implant 400 is expanded into the mitralvalve 12 as shown in FIGS. 59 and 60. When ready to implant, the hooks442 are extended into the wall of the heart. In FIG. 62, the implant 400is released from the delivery system 100 and the internal valve leaflets452 function to valve the blood flow.

FIGS. 63 to 67 illustrate an alternative embodiment of an activelycontrollable replacement mitral valve implant 500. This implant issimilar in structure to the implant 200 except the wall-retaining petals248 are not present Like implant 200, the implant 500 has an exteriorimplant skirt 540. The implant 500 can be substantially circular, but itis D-shaped in this mitral valve embodiment. As all other aspects of theimplant 500 are similar to the implant 200, all features are notrepeated to avoid unnecessary repetition. Likewise, where similar partsare referenced, the reference numeral is increased by 300. What isdifferent with the implant 500 is that the implant skirt 540 issupplemented with tissue-fixation structures in the form of extendiblehooks 542 that are part of or attached to the adjustable stent lattice410. The self-expanding valve trampoline lattice 530 is also present.The hooks 542 can take the form of the needles 1700 or 2200 or 3070shown and described in U.S. Patent Publication No. 2013/0046373 toCartledge et al.

Deployment of the implant 500 is performed just as implant 200. Thedelivery system 100 in FIG. 63 is guided along a non-illustratedguidewire to an implant site in the patient. The adjustable stentlattice 510 is allowed to self-expand after the sheath is removed andthen is forcibly expanded into the annulus of the mitral valve to afinal implant size, the implant 500 being reversibly expanded andcontracted as desired to achieve optimal deployment. As with implant200, when the sheath 130 is removed from the compressed implant 500, theimplant skirt 540 is allowed to self-expand on the ventricle side of themitral valve annulus. This expansion is shown in FIGS. 64 and 65 (thegraft material 535 of the implant 500 is not illustrated in FIG. 64).When the implant 600 is in the desired location and orientation and isready to be released, the extendible hooks 542 are extended out from thesides of the implant 500 to enter into and fixedly connect to the tissueat the implant site. Only three of the hooks 542 are illustrated in FIG.66 but this number is not to be limiting. In an exemplary embodiment,the number of hooks 542 is equal to the number of disconnect lumens 140,which in the embodiment shown would be six in number.

FIGS. 68 to 72 illustrate the process for deploying the implant 500 inthe mitral valve annulus of a heart. In contrast to the embodiment ofimplant 200, which is inserted through the atrium from above the heart,the implant 500 is inserted through a transapical approach. The deliverysystem 100 is inserted through the apex of the heart up through the leftventricle and through the mitral valve 12 to place the nosecone 120within the left atrium. The implant 500 is expanded into the mitralvalve 12 as shown in FIGS. 69 and 70. When ready to implant, the hooks542 are extended into the wall of the heart. In FIG. 72, the implant 500is released from the delivery system 100 and the internal,non-illustrated valve leaflets function to valve the blood flow.

FIG. 73 illustrates an exemplary embodiment of the implant 500, viewedfrom the atrium side thereof with the expandable outer trampolineportion 532 deployed and the leaflets 552 of the inner circumferentialvalve portion 534 in an almost closed state. FIGS. 74 and 75 show theskeleton of the implant 500 with the outer material and trampoline valveremoved. The implant skirt 540 comprises two parts, an outercircumferential ring 541 and a set of ring-connecting struts 543, whichconnect the ring 541 to the adjustable stent lattice 510. Both the ring541 and the struts 543 are made of a material that is self-expanding andhaving a desired, pre-set shape (such as heat-set nitinol, for example).The struts 543 can be integral with the ring 541 and/or the adjustablestent lattice 510 or connected thereto. The various parts of theadjustable stent lattice 510 are best viewed in FIG. 75. The adjustablestent lattice 510 comprises sets of jack screw connectors, each sethaving a proximal jack strut 512 and a distal jack strut 514. Arms 516connect each of the proximal and distal jack struts 512, 514 to anintermediate strut 518. Jack screws 520, which are non-illustrated forclarity but one is depicted as a dashed line in FIG. 75, connect to theproximal and distal jack struts 512, 514 so that, when the jack screw520 is turned in one direction, the proximal and distal jack struts 512,514 separate from one another and, when the jack screw 520 is turned inthe other opposite direction, the proximal and distal jack struts 512,514 move towards one another. This configuration can be achieved invarious ways. One exemplary embodiment fixes a non-illustrated threadednut within the distal jack strut 514 to allow the jack screw 520 tothreadedly enter into and retract from a smooth-bored hollow in thedistal jack strut 514 and places a rotationally free but longitudinallyfixed connection of the jack screw 520 at the proximal jack strut 512.In this manner, when the jack screw 520 is rotated in astrut-approaching direction, the distal end of the jack screw 520 movesinto the internal non-threaded bore of the distal jack strut 514 (viathe connection with threads of the nut) and the proximal end of the jackscrew 520 remains longitudinally fixed at the proximal jack strut 512but is allowed to rotate freely therein. As set forth above, theproximal end of the jack screw 520 has a connector part that isremovably connected to a drive wire connector 150 of a drive wire 150 sothat, when the drive wire connector 150 is caused to rotate, the jackscrew 520 rotates correspondingly. This connection is maintained in anyof the exemplary embodiments when the lattice disconnect tubes surroundboth the proximal end of the jack screw (referred to as a drivingconnector) and the drive wire connector 150. One way to form theremovable connection is through a form fit, such as two cylinders havinga mirrored handshake keying that only remains connected when a hollowcylindrical shroud encircles that connection. A form-locking orform-fitting connection is one that connects two elements together dueto the shape of the elements themselves, as opposed to a force-lockingconnection, which locks the elements together by force external to theelements.

With such a configuration, rotation of the many jack screws 520 in thestrut-approaching direction causes the proximal and distal jack struts512, 514 to move towards one another and, thereby, push the intermediatestruts 518 (which are disposed parallel to the jack screws 520) awayfrom the jack screw 520 in a direction along the circumferential extentof the annulus of the adjustable stent lattice 510. This relativemovement of the intermediate strut 518 and the jack screw assembliescauses expansion of the adjustable stent lattice 510 when the proximaland distal jack struts 512, 514 move towards one another and causescontraction of the adjustable stent lattice 510 when the proximal anddistal jack struts 512, 514 move away from one another. Ideally, all ofthe jack screws 520 are rotated at the same speed to but such equalmovement is not to be considered limiting.

In the exemplary embodiment of the adjustable stent lattice 510 shown,there are eight pairs of jack struts 512, 514 and eight intermediatestruts 518. This number is merely exemplary and there can be, forexample, only six of each or any other number desired including anynumber from 1 to 10. Connecting the pairs of jack struts 512, 514 andthe intermediate struts 518 are the laterally extending arms 516. As theadjustable stent lattice 510 is either contracted or expanded, the arms516 each flex at their two endpoints, one at a respective intermediatestrut 518 and the other at a respective one of a pair of jack struts512, 514. As can be seen from the configuration shown in FIG. 75, whenthe adjustable stent lattice 510 is contracted (e.g., for installationinto the delivery sheath 130), the arms 516 move towards a longitudinalorientation (parallel to the jack screws and to the central axis of thelattice 510. Conversely, when the adjustable stent lattice 510 isexpanded (e.g., for implantation), the arms 516 angle away from therespective intermediate strut 518 and one of the pair of jack struts512, 514 in a circumferential orientation (perpendicular to the jackscrews).

While this detailed description of the parts of the adjustable stentlattice 510 is present herein with respect to implant 500, it is equallyapplicable to the each of the alternative implant embodiments describedherein.

As stated above, the structures forming the various exemplaryembodiments for heart valves are not limited to only a single valve or asingle exterior shape. The features can be extended to alternativeconfigurations.

A first alternative configuration of a mitral valve replacement implant600 is shown in FIGS. 78 to 81. In the embodiment of FIGS. 2 to 13, themitral valve replacement implant 200 had the trampoline lattice 230projecting through the implant skirt 240 on the ventricle side of theimplant 200. The exemplary embodiment of the mitral valve replacementimplant 600 in FIGS. 78 to 81 provides the trampoline lattice 630 withthe inner circumferential valve portion 634 on the opposing side andprojecting out from the side of the implant 600 with the wall-retainingpetals 648. The expandable outer trampoline portion 632 is visible inFIG. 76. The framework of the implant 600 is shown without the externalcoverings and valve material in FIGS. 77, 79, and 81 to expose theadjustable stent lattice 610, the skirt lattice 642, and thewall-retaining petals 648.

A second alternative configuration of a circular valve replacementimplant 600 is shown in FIGS. 82 to 87. In the embodiment of FIGS. 78 to81, the implant 600 had an overall D-shape and the wall-retaining petals648 were uncovered. The exemplary embodiment of the valve replacementimplant 700 in FIGS. 82 to 87 likewise provides the trampoline lattice730 with the inner circumferential valve portion 734 on the sideopposite the implant skirt 740 projecting out from the side of theimplant 700 with the wall-retaining petals 748 but is circular in itsoverall shape. Both the expandable outer trampoline portion 732 and theinner circumferential valve portion 734 are visible in FIG. 82. As canbe seen, the material 744 of the implant skirt 740 also covers thewall-retaining petals 748. The framework of the implant 700 is shownwithout the external coverings and valve material in FIGS. 83, 85, and87 to expose the adjustable stent lattice 710, the skirt lattice 742,and the wall-retaining petals 748. Because the disconnect lumens 140 andthe drive wires 150 connect from the side of the wall-retaining petals748, the nosecone 120 is on the side of the implant skirt 740.

A third alternative configuration of a circular valve replacementimplant 800 is shown in FIGS. 88 to 93. In the embodiment of FIGS. 82 to87, the implant 700 had an overall circular shape and the wall-retainingpetals 748 were covered. Like the implant 700, the implant 800 iscircular in its overall shape. In contrast to the implant 700, however,the exemplary embodiment of the valve replacement implant 800 in FIGS.88 to 93 has the trampoline lattice 830 with the inner circumferentialvalve portion 834 on the side opposite the wall-retaining petals 848 toproject out from the side of the implant 800 having the implant skirt840. The expandable outer trampoline portion 832 is visible from theinterior of the implant 800 in FIG. 88 and the inner circumferentialvalve portion 834 is visible in both FIGS. 90 and 92. As can be seen,the material 844 of the implant skirt 840 does not cover thewall-retaining petals 848, but it does project into the central orificesdefined by each petal 848 in order to cover the proximal jack strut 812.The framework of the implant 800 is shown without the external coveringsand valve material in FIGS. 89, 91, and 93 to expose the adjustablestent lattice 810, the skirt lattice 842, and the wall-retaining petals848. Because the disconnect lumens 140 and the drive wires 150 connectfrom the side of the wall-retaining petals 848, the nosecone 120 is onthe side of the implant skirt 840.

A fourth alternative configuration of a circular valve replacementimplant 900 is shown in FIGS. 94 and 95. In contrast to the previousexemplary embodiments, the implant 900 has no exterior skirt, has nowall-retaining petals, and does not have the trampoline valve. Theimplant 900 has an overall circular shape and a tricuspid valve withleaflets 952 attached to the interior of the adjustable stent lattice910.

A fifth alternative configuration of a circular valve replacementimplant 1000 is shown in FIGS. 96 to 99. In contrast to the previousexemplary embodiments, the implant 1000 has a self-expanding valvetrampoline lattice 1030 but it does not have an exterior skirt orwall-retaining petals. The trampoline lattice 1030 has an innercircumferential valve portion 1034 on a side where the disconnect lumens140 project out from the proximal end of the adjustable stent lattice1010. The expandable outer trampoline portion 1032 is visible from theinterior of the implant 1000 in FIG. 96 and the inner circumferentialvalve portion 1034 is visible in both FIGS. 96 and 97 with the internalleaflets 1052 is visible in FIG. 97. The framework of the implant 1000is shown without the external coverings and valve material in FIGS. 98and 99 to expose the adjustable stent lattice 1010 and the trampolinelattice 1030. Because the disconnect lumens 140 and the drive wires 150connect from the side of the inner circumferential valve portion 1034,the nosecone 120 is on the side opposite the inner circumferential valveportion 1034.

A sixth alternative configuration of a circular valve replacementimplant 1100 is shown in FIGS. 100 to 102. In contrast to the previousexemplary embodiments, the implant 1100 has an exterior implant skirt1140 but it does not have self-expanding valve trampoline lattice orwall-retaining petals. The valve contained within the adjustable stentlattice 1110 has three leaflets 1152, which are shown in FIGS. 100 and101. The implant 1100 is installed from the side of the adjustable stentlattice 1110 having the implant skirt 1140, the side where thedisconnect lumens 140 project out from the proximal end of theadjustable stent lattice 1110. Because the disconnect lumens 140 and thedrive wires 150 connect from the side of the implant skirt 1140, thenosecone 120 is on the side opposite the implant skirt 1140, as shown inFIG. 101.

The framework of the implant 1100 is shown without the externalcoverings and valve material in FIG. 102 to expose the adjustable stentlattice 1110 and the lattice of the skirt 1140, as well as their variouscomponents. The implant skirt 1140, in this exemplary embodimentcomprises only one part, an outer circumferential ring. This implantskirt 1140 does not connect to the adjustable stent lattice withintervening struts as in some of the above embodiments. The skirt 1140is made of a material that is self-expanding and has a desired, pre-setshape (such as heat-set nitinol, for example). The adjustable stentlattice 1110 comprises sets of jack screw connectors, each set having aproximal jack strut 1112 and a distal jack strut 1114. Arms 1116 connecteach of the proximal and distal jack struts 1112, 1114 to anintermediate strut 1118. Jack screws 1120 connect to the proximal anddistal jack struts 1112, 1114 so that, when the jack screw 1120 isturned in one direction, the proximal and distal jack struts 1112, 114separate from one another and, when the jack screw 1120 is turned in theother opposite direction, the proximal and distal jack struts 1112, 1114move towards one another. This configuration can be achieved in variousways as described above and, therefore, this is not repeated here.

With such a configuration, rotation of the many jack screws 1120 in thestrut-approaching direction causes the proximal and distal jack struts1112, 1114 to move towards one another and, thereby, push theintermediate struts 1118 (which are disposed parallel to the jack screws1120) away from the jack screw 1120 in a direction along thecircumferential extent of the annulus of the adjustable stent lattice1110. This relative movement of the intermediate strut 1118 and the jackscrew assemblies causes expansion of the adjustable stent lattice 1110when the proximal and distal jack struts 1112, 1114 move towards oneanother and causes contraction of the adjustable stent lattice 1110 whenthe proximal and distal jack struts 1112, 1114 move away from oneanother. Ideally, all of the jack screws 120 are rotated at the samespeed to but such equal movement is not to be considered limiting.

In the exemplary embodiment of the adjustable stent lattice 1110 shown,there are eight pairs of jack struts 1112, 1114 and eight intermediatestruts 1118. This number is merely exemplary and there can be, forexample, only six of each or any other number desired including anynumber from 1 to 10. Connecting the pairs of jack struts 1112, 1114 andthe intermediate struts 1118 are the laterally extending arms 1116,which, in this exemplary embodiment is two for each of the proximal anddistal jack struts 1112, 1114, but this number is not limiting. As theadjustable stent lattice 1110 is either contracted or expanded, the arms1116 each flex at their two endpoints, one at a respective intermediatestrut 1118 and the other at a respective one of a pair of jack struts1112, 1114. When the adjustable stent lattice 1110 is contracted (e.g.,for installation into the delivery sheath 130), the arms 1116 movetowards a longitudinal orientation (parallel to the jack screws and tothe central axis of the lattice 1110. Conversely, when the adjustablestent lattice 1110 is expanded (e.g., for implantation), the arms 1116angle away from the respective intermediate strut 1118 and one of thepair of jack struts 1112, 1114 in a circumferential orientation(perpendicular to the jack screws).

A seventh alternative configuration of a circular valve replacementimplant 1200 is shown in FIGS. 103 and 104. In contrast to the previousexemplary embodiments, the implant 1200 has an exterior implant skirt1240 and a self-expanding valve trampoline lattice 1230 but it does nothave wall-retaining petals. The trampoline lattice 1230 has an innercircumferential valve portion 1234 on the side of the implant skirt 1240where the disconnect lumens 140 project out from the proximal end of theadjustable stent lattice 1210. The expandable outer trampoline portion1232 is visible from the interior of the implant 1200 in FIG. 103 andthe inner circumferential valve portion 1234 is visible in FIG. 104 withthe internal leaflets 1252 also visible there, three in number in thisexample. The implant 1200 is installed from the skirt side of theadjustable stent lattice 1210 where the inner circumferential valveportion 1234 exists and the side where the disconnect lumens 140 projectout from the proximal end of the adjustable stent lattice 1210. Becausethe disconnect lumens 140 and the drive wires 150 connect from the sideof the inner circumferential valve portion 1234, the nosecone 120 is onthe side opposite the inner circumferential valve portion 1234.

In the above embodiments, memory shape and other metallic lattices weredescribed. These lattices can have a material thickness of between 0.6mm (0.024″) and 0.9 mm (0.035″) and any number therebetween, inparticular between 0.7 mm (0.028″) and 0.8 mm (0.032″) and any numbertherebetween.

With mitral valve replacement implants having a trampoline valve, thenumber of sizes needed to cover the range of patient population isdecreased from prior art TAVR replacement valves, which generallyrequires at least four sizes to be available for use. For the trampolinevalves described herein, a 22 mm diameter valve can reside within avalve trampoline lattice having an expanded diameter starting atapproximately 25 mm at its smallest to approximately 40 mm at itslargest size. A 30 mm diameter valve can reside within a valvetrampoline lattice having an expanded diameter starting at approximately40 mm at its smallest to approximately 55 mm at its largest size. With avalve diameter range of between 25 mm and 55 mm, this means that theherein-described mitral valve implants having valve trampolines cancover the entire range of expected patient population with only twosizes.

The catheter sheaths required to implant these two are approximately 28Fr to 32 Fr for the 25 mm to 40 mm size and 32 Fr to 35 Fr for the 40 mmto 55 mm size. Well within the desired range of catheters for such valvereplacement procedures. It is further noted that if porcine pericardiumis used for the valve leaflets, the size of the delivery sheath can bereduced, in particular, to 25 Fr to 29 Fr and 29 to 32 Fr, respectively.

It is noted that various individual features of the inventive processesand systems may be described only in one exemplary embodiment herein.The particular choice for description herein with regard to a singleexemplary embodiment is not to be taken as a limitation that theparticular feature is only applicable to the embodiment in which it isdescribed. All features described herein are equally applicable to,additive, or interchangeable with any or all of the other exemplaryembodiments described herein and in any combination or grouping orarrangement. In particular, use of a single reference numeral herein toillustrate, define, or describe a particular feature does not mean thatthe feature cannot be associated or equated to another feature inanother drawing figure or description. Further, where two or morereference numerals are used in the figures or in the drawings, thisshould not be construed as being limited to only those embodiments orfeatures, they are equally applicable to similar features or not areference numeral is used or another reference numeral is omitted.

The foregoing description and accompanying drawings illustrate theprinciples, exemplary embodiments, and modes of operation of thesystems, apparatuses, and methods. However, the systems, apparatuses,and methods should not be construed as being limited to the particularembodiments discussed above. Additional variations of the embodimentsdiscussed above will be appreciated by those skilled in the art and theabove-described embodiments should be regarded as illustrative ratherthan restrictive. Accordingly, it should be appreciated that variationsto those embodiments can be made by those skilled in the art withoutdeparting from the scope of the systems, apparatuses, and methods asdefined by the following claims.

What is claimed is:
 1. A mitral valve implant, comprising: an expandablemitral valve lattice having an inflow end portion and an outflow endportion; a self-expanding valve trampoline lattice attached to theoutflow end portion of the mitral valve lattice; a self-expanding skirtlattice attached to an exterior surface of the mitral valve lattice,wherein the skirt lattice is covered by a fluid-resistant material; anda plurality of jack screws rotatably connected to the mitral valvelattice, wherein the mitral valve lattice is configured to self-expandfrom a compressed configuration to a first expanded configuration, andwherein the jack screws are configured to expand the mitral valvelattice from the first expanded configuration to a second expandedconfiguration, which is radially larger than the first expandedconfiguration.
 2. The implant according to claim 1, wherein the firstexpanded configuration is one of circular and D-shaped.
 3. The implantaccording to claim 2, wherein the second expanded configurationcorresponds in shape to the one of circular and D-shaped first expandedconfiguration.
 4. The implant according to claim 1, wherein the jackscrews are configured to compress the mitral valve lattice from thesecond expanded configuration to the first expanded configuration. 5.The implant according to claim 1, wherein the mitral valve lattice ismade of a shape memory material and is shape-set to the first expandedconfiguration.
 6. The implant according to claim 1, wherein the valvetrampoline lattice has a cylindrical central region comprising valveleaflets.
 7. The implant according to claim 6, wherein the valvetrampoline lattice comprises a D-shaped portion.
 8. The implantaccording to claim 7, wherein: the valve leaflets have an inflow side;and the D-shaped portion is located on an inflow side of the valveleaflets.
 9. The implant according to claim 1, wherein the skirt latticehas an outflow end portion that extends radially outwardly relative tothe mitral valve lattice and has a first outer diameter, and wherein thefirst outer diameter of the skirt lattice is larger than a second outerdiameter of the valve trampoline lattice.
 10. The implant according toclaim 9, wherein the skirt lattice has an inflow end portion comprisingwall-retaining wires extending radially outwardly relative to the mitralvalve lattice, wherein the wall-retaining wires are shaped to bepositioned on a side of the native mitral valve.
 11. The implantaccording to claim 10, wherein the wall-retaining wires are in the shapeof petals and have a pre-set, radially outward, memory shape to impart aforce on the side of the native mitral valve when the mitral valvelattice is expanded within an annulus of the native mitral valve. 12.The implant according to claim 11, wherein: the outflow end portion ofthe skirt lattice is shaped to be positioned on a ventricular side ofthe native mitral valve when the mitral valve lattice is expanded withinthe annulus of the native mitral valve; and the wall-retaining wires ofthe skirt lattice are shaped to be positioned on an atrial side of thenative mitral valve when the mitral valve lattice is expanded within theannulus of the native mitral valve.
 13. The implant according to claim1, wherein the valve trampoline lattice has an inflow end portionattached to the outflow end portion of the mitral valve lattice, andwherein the skirt lattice has an outflow end portion that has a largerdiameter than diameters of the inflow end portions of the mitral valvelattice and the valve trampoline lattice.
 14. The implant according toclaim 1, wherein when the mitral valve lattice is in the second expandedconfiguration, an outflow end portion of the valve trampoline lattice isspaced radially inwardly from the outflow end of the mitral valvelattice.